Kornimate/medical-research-clean huggingface dataset:
trajectories of cardiac allograft vasculopathy after heart transplantation

Conditions: Heart Transplantation; Allograft Arteriopathy

Summary: this project aims: i) to identify cardiac allograft vasculopathy (cav) trajectories after heat transplantation using latent class mixed modeling, ii) to characterize the global and specific determinants of different trajectories and iii) to provide an easily accessible tool to project individual probability of cav trajectory belonging.

background: cardiac allograft vasculopathy (cav) is the third cause of late mortality and the leading cause of late allograft dysfunction. the field of heart transplantation currently lacks longitudinal description of cav profiles. identifying relevant cav trajectories, or evolution profiles, and their respective determinants is an unmet clinical need. cav trajectories requires an additional level of understanding and characterization over the current paradigm. understanding the mechanisms and clinical factors involved in the development of cav will be useful to provide a more nuanced picture of disease progression, which may ultimately contribute to risk stratification and ultimately guiding the care of htx patients. main outcome(s) and measure(s): * identification of cav trajectories after transplantation using an unsupervised latent class mixed modeling. cav angiograms were recorded per center protocol for all patients after transplantation. cav was graded according to the current ishlt classification as cav 0 (not significant), 1 (mild), 2 (moderate) and 3 (severe). * determination of clinical, functional, structural, immunological factors associated with the trajectories. in the derivation cohort, the associations between cav trajectories and clinical, histological, functional, and immunological parameters at the time of transplantation, during the first year and at one-year post-transplant were assessed using multinomial logistic regression.

Eligibility criteria:
inclusion criteria: * heart recipient with at least two coronary angiograms after heart transplantation, * heart recipient over 18 years of age. exclusion criteria: * patient with \< 2 coronary angiograms during follow-up
tissue therapy of transsphincteric anal fistula

Conditions: Anal Fistula

Summary: this clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (paf) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

after being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. the first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. the rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (adrc adipose-derived regeneative cells) or donated cultured regenerative cells (adrc001). all included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.

Eligibility criteria:
inclusion criterion: adult patients (\>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at odense university hospital for treatment, and who are: * able to communicate with danish language * able to provide informed consent * having address in the region of southern denmark during the study exclusion criteria: 1. signs of suppuration/cavitation around the fistula 2. simple or low anal fistula, which can be treated by simple surgical incision 3. ano-vaginal and recto-vaginal fistula 4. the presence of more than one fistula tract, more than two external orifices or more than one internal orifice 5. inflammatory bowel disease 6. immunosuppression (due to clinical condition or medical therapy) 7. malignancy within 5 years 8. previous radiotherapy of the abdomen and pelvis 9. bmi under 18.5 10. allergy against the antibiotics: penicillin and streptomycin. 11. coagulopathy 12. pregnancy and lactation (positive hcg (human chorionic gonadotropin) test) 13. verified syphilis, hiv, or hepatitis on screening test

Keywords: anal fistula stem cells adrc
myocardial injury in treatment of aaa

Conditions: Aortic Aneurysm, Abdominal; Complication of Surgical Procedure; Myocardium; Ischemic

Summary: comparison of elective infrarenal aneurysm surgery with open and endovascular technique, respectively, for subclinical ischemic myocardial injury detectable with troponin t and/or 3-channel holter ecg with st analysis

background: traditional open surgery for abdominal aortic aneurysm (aaa) is burdened with complication risk from several organ systems, and also mortality figures of 3.5 - 5.5%. over 50% of early mortality can be attributed to cardiovascular complications. myocardial infarction is the dominant organ-specific cause of both early and late mortality in patients operated on for aaa. endovascular surgery (endovascular aortic repair, evar) was developed during the 90's as an alternative method that is considered less invasive and more well-tolerated from a cardiovascular perspective. troponin t is a very sensitive and specific marker that predicts mortality in patients with acute symptoms of unstable angina and/or heart attack. previous studies have also shown a high incidence of elevated troponin levels in patients who underwent major surgical procedures, especially vascular surgery, even in the absence of corresponding clinical or ecg-related symptoms of cardiac muscle injury. several studies have also demonstrated that elevated troponin levels after surgery predict increased morbidity and mortality both short-term and long-term. objective: to prospectively compare elective open and endovascular surgery of aaa with respect to myocardial injury detectable with troponin t. furthermore, to compare open and endovascular aaa surgery for the total number of periods of oxygen deficiency in cardiac muscle during and at early stages after surgery using a special ecg method (48-hour 3-channel holter ecg with st analysis). main aim of the study: to assess whether evar induce less myocardial injury compared with open repair for aaa. significance: myocardial infarction is the predominant cause of mortality in open surgical procedure for aaa. in several previous studies, troponin t rise has been associated with impaired both short-term and long-term prognosis in elderly patients undergoing major elective surgery. this study may provide information on whether the endovascular technique provides a reduction in myocardial injury, measured as elevated troponin t or myocardial ischemia with 3-channel holter ecg. in this way, our study can provide improved decision support in the choice of the most appropriate treatment method in the individual case.

Eligibility criteria:
inclusion criteria: * accepted for aaa surgery of either one of the operative techniques exclusion criteria: * high anesthesiological risk * preoperative cardiac condition with ef \< 25 or ischemic signs on preoperative evaluation * severe renal insufficiency with s-creatinine \>200

Keywords: aaa myocardial ischemic injury troponin holter-ecg vascular surgery
effects of vestibular rehabilitation in the treatment of dizziness and balance disturbances after concussion

Conditions: Concussion

Summary: the goal of this clinical trial is to study the effects of including vestibular rehabilitation in the treatment of dizziness and balance disturbances in athletes after concussion. the main questions it aims to answer are: * does inclusion of vestibular rehabilitation treatment have an effect on symptom resolution in those with concussion? * does inclusion of vestibular rehabilitation treatment have an effect on the rate of recovery and return to play after concussion? researchers will compare vestibular rehabilitation treatment inclusion in concussion treatment to a traditional concussion treatment approach to see if the rate of symptom resolution and return to play are affected by including vestibular rehabilitation for participants who have experienced a concussion within one week of presenting for the study. participants will: * be randomly assigned to either receive vestibular rehabilitation included in their concussion treatment or have traditional concussion treatment without vestibular rehabilitation. * complete treatment sessions two times per week for up to four weeks * complete the corresponding home program for the treatment group * complete baseline symptom testing and repeat the symptom testing at study completion for data comparison. testing includes: sport concussion assessment tool (scat5) including 1) the athlete's background 2) symptom evaluation 3) cognitive screening 4) neurological screening and 5) delayed recall, a dynamic gait index (dgi) including 1) gait on level surface 2) change in gait speed 3) gait with horizontal head turns 4) gait with vertical head turns 5) gait and pivot turn 6) step over obstacle 7) step around obstacle 8) stairs, and a vestibular evaluation including 1) patient history 2) visual assessment 3) vertebral artery clearance 4) cervical spine clearance 5) inner ear assessment 6) brief balance assessment.

nothing further to include that is not entered or uploaded elsewhere in the record

Eligibility criteria:
inclusion criteria: * athlete from a small regional university * experiences a concussion * identified by their certified athletic trainer to have dizziness or balance dysfunctions * referred for initial contact testing and treatment exclusion criteria: * acute spinal cord injury with neurological deficits * epidural and subdural hematoma with known manifestations * acute cervical spine injury

Keywords: vestibular rehabilitation concussion dizziness balance disturbances
interest of a standardized monitoring of rheumatoid arthritis: the comedra trial

Conditions: Rheumatoid Arthritis

Summary: the two objectives of this trial are :1 to evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. indication to statin, antiaggregant,anti-hypertensive treatment...), cancers (e.g.mammography,...), osteoporosis (e.g. bone densitometry,..) in patients suffering from rheumatoid arthritis 2 to evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the disease activity score (das28-esr).

patients with a stable definite rheumatoid arthritis will be invited by their rheumatologists to participate at this study in 20 centers in france. after written informed consent will be obtained, the patients will be randomized in two arms: * comorbidities * auto-das the patients will be seen again in the same center six months later in order to collect the outcome measures.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis * stable (no change in therapy) * adult * able to collaborate exclusion criteria * pregnant woman * change of the therapy for 3 months before the inclusion * alcoholism, toxicomania, psychological problem, sever co morbidity which could invalid the consent or limit the protocol compliance * no social coverage affiliate

Keywords: 1 rheumatoid arthritis 2 education 3 co-morbidities 4 nurse
hkt288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma

Conditions: Epithelial Ovarian Cancer; Renal Cell Carcinoma

Summary: a first-in-human study using hkt288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma


Eligibility criteria:
main inclusion criteria: * advanced (metastatic or locally advanced) serous epithelial ovarian, serous fallopian tubal or serous primary peritoneal cancer or advanced clear cell or papillary renal cell carcinoma who have received or are intolerant to all therapy known to confer clinical benefit for their disease, as determined by the investigator. * tumor sample is available for retrospective cdh6 expression testing * eastern cooperative oncology group (ecog) performance status ≤2 main exclusion criteria: * patient has central nervous system metastatic involvement. patients with previously treated cns metastases are also excluded. * patient with any active or chronic corneal disorders * patients with monocular vision or have media opacities or any other condition that precludes monitoring of the retina or fundus. * patients with a history of serious allergic reactions * patients with qtcf \>470 msec at screening ecg or congenital long qt syndrome * any prior history of treatment with maytansine (dm1 or dm4)-based adc * patient have received anti-cancer therapies within the following time frames prior to the first dose of study treatment: * conventional cytotoxic chemotherapy: ≤4 weeks (≤ 6 weeks for nitrosoureas and mitomycin-c) * biologic therapy (e.g., antibodies): ≤4 weeks * non-cytotoxic small molecule therapeutics: ≤5 half-lives or ≤2 weeks (whichever is longer) * other investigational agents: ≤4 weeks * radiation therapy (except for localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture): ≤4 weeks * radiation therapy (localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture) ≤2 weeks * major surgery: ≤2 weeks

Keywords: hkt288 cdh6 adc maytansine epithelial ovarian cancer renal cell carcinoma rcc
ezetimibe (sch 58235) taken with either atorvastatin or simvastatin in participants with familial hypercholesterolemia (mk-0653-018)

Conditions: Familial Hypercholesterolemia

Summary: the primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (sch 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (fh).


Eligibility criteria:
inclusion criteria: * with a diagnosis of homozygous familial hypercholesterolemia * all females must have a negative pregnancy test prior to study entry. women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study, until one month after treatment. * postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ert), estrogen/progestin (hrt) or raloxifene regimen during the study period. ert, hrt or raloxifene cannot be changed during study period. * must follow prescribed or stricter diet, and demonstrate completion of diet diaries exclusion criteria: * a history of mental instability, drug or alcohol abuse; or have been treated or are being treated for severe psychiatric illness which, in the opinion of the investigator, may interfere with optimal participation in the study. * with underlying disease likely to limit life span to less than 1 year. * have previously been randomized in any studies examining ezetimibe * pregnant or lactating women. * with known hypersensitivity or any contraindication to statin therapy.
surescan post-approval study

Conditions: Bradycardia

Summary: the purpose of this post-approval study (pas) is to demonstrate the chronic performance of the surescan pacing system when used in an mri environment according to product labeling. this study is required by the food and drug administration (fda) as a condition of product approval.


Eligibility criteria:
inclusion criteria: 1. subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements 2. subject is or intended to be implanted with a complete surescan pacing system consisting of both a right atrial and ventricular 5086mri lead (used for pacing and sensing) and a surescan device 3. subject within 30 days of implant (maximum 50% of chronic performance arm enrollment) or subject enrolled into multiple mri scan arm at the time of mri scan indication exclusion criteria: 1. subject who is, or will be inaccessible for follow-up 2. implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable 3. subject with exclusion criteria required by local law

Keywords: mr conditional
plant-based dietary protein and resistance-training adaptations

Conditions: Healthy

Summary: dietary protein consumption maximizes the anabolic response during resistance training (rt) by triggering muscle protein synthesis and providing the indispensable amino acids for a net positive protein balance. leucine is considered the key amino acid in this process, suggesting that differences in protein quality may influence rt-induced gains in muscle mass and strength. in general, plant-based protein sources have lower leucine concentrations than animal-based protein sources and human skeletal muscle. in this respect, despite acute evidence on lower anabolic properties of plant- vs. animal-based protein, the effects of an exclusive plant-based dietary protein diet on rt-induced adaptations are currently unknown.


Eligibility criteria:
inclusion criteria: * healthy young men * vegans ≥ 1 y or omnivorous subjects * physically active but no resistance-trained subjects * without any chronic injury that impairs resistance training performance * protein intake \> 0.8 g/protein/kg body weight exclusion criteria: * use of creatine or beta-alanine supplements for the last 3 months * use of proteins and/or amino acids supplements for the last 1 month * engagement in specific dietary restrictions * previous use of anabolic steroids * engagement in any training program

Keywords: protein source hypertrophy resistance training plant-based protein omnivorous
ha residents with pvd, pulmonary artery pressure (pap) assessed at ha (2840m) with and without supplemental oxygen therapy (sot)

Conditions: Pulmonary Vascular Disorder; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Summary: to study the effect of sot in patients with pulmonary vascular diseases (pvd) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (ph) who permanently live \>2500m on pulmonary artery pressure (pap) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without sot.

patients with pvd diagnosed with precapillary ph with right heart catheterization and classified to groups 1 and 4 (pah or cteph) who permanently live at ha \>2500 (pvdha) will have echocardiografy to assess pap, cardiac output and other hemodynamics and arterial blood gas to assess sao2, pao2 and paco2 near their living altitude in quito at 2840m whilst breathing ambient air or sot at 10l/min flow via a face mask with reservoir.

Eligibility criteria:
inclusion criteria: * adult patients 18-80 years old of both genders, * residence \> 2500m of altitude * diagnosed with precapillary ph (mean pulmonary artery pressure (mpap) \>20 mmhg, pulmonary artery wedge pressure (pawp) ≤15 mmhg and pulmonary vascular resistance (pvr) ≥2 wood units (wu) by right heart catheterization) with ph being classified as pah or cteph according to guidelines * patients stable on therapy * new york heart association (nyha) functional class i-iii * provided written informed consent to participate in the study. exclusion criteria: * age \ 80 years * unstable condition * patients who cannot follow the study investigations, patient permanently living \< 2500m. * patients with moderate to severe concomitant lung disease (fev1\ 20 cigarettes/day) * severely hypoxemic patients at quito permanently have persistent oxygen saturation by pulseoximetry (spo2) \<80% on ambient air. * patients with chronic mountain sickness (hemoglobin \> 19 g/dl in women, \>21 g/dl in men) * patient with a non-corrected ventricular septum defect * relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)

Keywords: pulmonary hypertension hypoxia supplemental oxygen 6-minute walk distance
drug interaction study between azd3480 and aripiprazole in healthy subjects

Conditions: Alzheimer's Disease

Summary: the purpose of the study is to evaluate if azd3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.


Eligibility criteria:
inclusion criteria: * provision of signed written informed consent * clinically normal physical findings and laboratory values exclusion criteria: * clinically significant illness or clinically relevant trauma within three weeks before the first dose * history of clinically significant disease * use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Keywords: alzheimer's disease azd3480 aripiprazole